Resources
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Impact of COVID-19 on Next Generation Sequencing Applications for Adventitious Virus Detection in Vaccine Manufacturing
Speaker Presentation Khan Arifa, CBER, FDA, 2021
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Academic Knowledge & Innovation to Accelerate Successful
Technological Transfer for a COVID-19 Vaccine
Speaker Presentation Bottazzi Maria Elena, Baylor College of Medicine, 2021
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Production of Anti-Coronavirus Disease 2019 Hyperimmune
Globulin from COVID-19 Convalescent Plasma
Speaker Presentation Willis Todd, Grifols, 2021
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Building COVID-19 Testing Capacity from Scratch
Speaker Presentation Storgaard Guldberg Torben, Novo Nordisk A/S, 2021
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Emergency Use Diagnostics in a Pandemic: A Global Perspective
Speaker Presentation Miller Danelle, Roche Diagnostics, 2021
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The Role of Emergency Use Authorization (EUA) in Coivd-19 Diagnostics
Speaker Presentation Karsner Ryan, CDRH, FDA, 2021
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Clinical Development of COVID-19 Vaccines
Speaker Presentation Krause Philip, CBER, FDA, 2021
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Global Comparability/Characterization Strategy for NVX-CoV2373
Speaker Presentation Schenerman Mark, Novavax Inc., 2021
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Overview of Cross-company (Trade Associations) Discussion on CMC Approaches to Support Development and Supply of COVID Vaccines
Speaker Presentation Campa Cristiana, GlaxoSmithKline, 2021
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Engineering Cell Lines for AAV Cell-based Potency Assays
Speaker Presentation Whipple Stephanie, Genzyme, a Sanofi Company, 2021
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Bioassays as Part of an Integrated Control Strategy
Speaker Presentation Van der Plas Martijin, Medical Evaluations Board (MEB), 2021
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Bioassay Evolution – Where Are We Now?
Speaker Presentation Mire-Sluis Anthony, AstraZeneca, 2021
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Potency Assays for Engineered Cell Therapies
Speaker Presentation Lowe Emily, Kite, a Gilead Company, 2021
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The Power of Proper System Suitability Tests - A Case Study of cGMP Method Improvement
Speaker Presentation Li Ruojia, Bristol-Myers Squibb Company, 2021
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Development of a New Cell Adhesion Bioassay Format
Speaker Presentation Kröner Frieder, Novartis Pharma KG, 2021
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Potency Assay Strategy for a Fixed-Dose Combination Product
Speaker Presentation Avenal Cécile, F. Hoffmann - La Roche AG, 2021
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Enhancing the Speed of Vaccine Development by Utilizing Fullt Automated High Throughput Cell Potency Assays
Speaker Presentation Acevedo-Skrip Jillian, Merck & Co. Inc., 2021
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PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals
Speaker Presentation Honda Futaba, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
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Communications, Regulatory Flexibilities and Quality Challenges for Biologics in the COVID19 Pandemic: An EMA Perspective
Speaker Presentation Shivji Ragini, European Medicines Agency, 2020
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Regulatory Challenges: Expediting CMC Development While Ensuring Product Quality
Speaker Presentation Levis Robin, CBER, FDA, 2020